Press
Release
Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
Sanofi presents R&D strategy
and innovative pipeline
·
Robust pipeline expected to support long-term growth
·
9 planned regulatory submissions over next 18 months
·
At least 10 pivotal phase 3 studies expected to begin over next 12
months
·
R&D model leverages new proprietary technology
platforms,
multi-targeting molecules and biologics
PARIS, France -
13 December 2017 - Sanofi will host an analyst meeting in Paris
today to discuss the company's Research and Development strategy,
development pipeline and milestones for 2018. The company will
highlight the progress it has made against "Sustaining Innovation",
a key pillar of its 2020 strategic roadmap, and advancing a
differentiated portfolio addressing unmet needs.
The company's pipeline spans 71
R&D projects, which includes 37 new molecular entities and
novel vaccines. At least 10 pivotal phase 3 studies are expected to
start over the next 12 months and will evaluate new treatments
for:
-
chronic obstructive pulmonary disease and
eosinophilic esophagitis (dupilumab[1]);
-
autosomal dominant polycystic kidney disease
(ADPKD), a rare kidney disease (venglustat);
-
type 2 diabetes (efpeglenatide, a once-weekly
GLP-1 agonist);
-
obesity (a GLP-1/GCG dual agonist);
-
primary progressive multiple sclerosis
(alemtuzumab), and;
-
first line NSCLC[2]
(cemiplimab).
Regulatory filings expected in the
next 12 months include two investigational cancer drugs (cemiplimab
and isatuximab), a novel therapy for type 1 diabetes
(sotagliflozin) and a potential treatment for uncontrolled,
persistent asthma (dupilumab).
"We have seen
significant advancement on our ambition to sustain innovation in
R&D, with the development of leading technology platforms and
proof of concept demonstrated in multiple high-potential projects
in late stage trials. We are confident this portfolio will be the
foundation for Sanofi's future long-term growth," said Olivier
Brandicourt, MD, Chief Executive Officer at Sanofi.
As a key pillar of the 2020
Roadmap, the new Sanofi R&D model is based on three key
strategic shifts:
-
From small molecules to biologics;
-
From mono-targeting to multi-targeting
compounds; and
-
From licensing to proprietary assets.
The company has continuously
adapted its R&D model in recent years to deliver greater
efficiency and excellence in development, resulting in a major
uplift in productivity. Since 2016, consistent with the three key
strategic shifts outlined above, Sanofi has placed increasing
emphasis on developing proprietary technology platforms, including
multi-specific antibodies (bi- & tri-specific), siRNA, trigonal
peptides, dual and triple agonists, and PRR-Antibody conjugates. It
has also leveraged external expertise in targeted platforms such as
mRNA mixtures and Nanobodies®.
"We aim to
advance multi-targeting therapeutic approaches for core disease
pathways that have the potential to attack more than one disease at
a time or bring improved risk benefit in the treatment of a single
disease," said Elias Zerhouni, MD, Global Head of R&D at
Sanofi. "2018 will be an important year as we expect multiple
milestones for Sanofi's late-stage pipeline, made possible through
the prioritization principles we have consistently applied to our
early-stage research programs."
Building a competitive position
in Specialty Care
Immunology
Sanofi is strengthening its specialty care portfolio and has
executed launches in its fast-growing immunology franchise.
Dupilumab, which we are developing in collaboration with Regeneron,
has potential across multiple indications. Phase 3 trials for
uncontrolled, persistent asthma recently demonstrated a potentially
clinically important profile among biologic treatments. Submission
in this important indication is expected before the end of 2017.
Clinical development is underway in nasal polyposis, eosinophilic
esophagitis, food allergies and in pediatric populations in most of
these indications. Additionally, phase 3 development for dupilumab
is now planned in chronic obstructive pulmonary disease (COPD).
Sanofi, in collaboration with Regeneron, also expects to bring
SAR440340, an anti-IL-33 antibody, which has the potential for a
broader spectrum of immune modulation, into phase 2 in atopic
dermatitis, asthma and COPD in 2018, alone or in combination with
dupilumab.
Oncology
Sanofi is committed to re-building its position in oncology and has
made major progress in the past two years. This strategy is
starting to deliver and we anticipate 14 new proof-of-concept
studies to be initiated, four potential proof-of-concept readouts,
six phase one starts and three BLA/ MAA submissions in 2018.
Cemiplimab is an investigational PD-1 checkpoint inhibitor and the
backbone of our checkpoint immuno-oncology strategy with our
partner Regeneron. It is being studied in cutaneous squamous cell
carcinoma (CSCC), for which it was granted "Breakthrough Therapy"
designation by the U.S. Food and Drug Administration (FDA), with an
expected regulatory submission in Q1 2018. The development program
also includes large or untapped opportunities in immuno-oncology,
such as basal cell carcinoma, cervical cancer, and first line lung
cancer.
Isatuximab is a Sanofi
investigational antiCD38 monoclonal antibody with a first
regulatory submission expected in 2018 for relapsed refractory
multiple myeloma (RRMM). Beyond multiple myeloma, and building on
the emerging evidence that CD38 inhibition may reverse resistance
to PD-L1, isatuximab will be studied in combination with cemiplimab
or other immuno-oncology agents. Sanofi will also present early
research programs for its Selective Estrogen Receptor Degrader
(SERD) and TGF-beta program to overcome PD-1 resistance.
Multiple Sclerosis
In multiple sclerosis (MS), Sanofi plans to build on the proven
long-term clinical profile of Lemtrada® (alemtuzumab)
by initiating a Phase 3 study in 2018 for alemtuzumab in patients
with primary progressive multiple sclerosis (PPMS). Consistent with
Sanofi's rigorous prioritization methodology, the company will
deprioritize GLD-52 in this indication in favor of
alemtuzumab. In addition, Sanofi, in collaboration with
Principia, will be developing a novel Bruton's tyrosine kinase
(BTK) inhibitor, designed to access the brain and spinal cord by
crossing the blood-brain barrier and impact immune cell and brain
cell signaling. It is currently being studied in MS with potential
applications in other central nervous system diseases[3].
Sustaining leadership in Rare
Disease, Diabetes & Cardiovascular and Vaccines
Rare
Disease
Sanofi's Rare Disease pipeline is structured with the goal of
sustaining innovation in lysosomal storage disorders, while also
expanding strategically into related conditions. Clinical
development programs include venglustat, an oral inhibitor of
glucosylceramide synthase, in Fabry Disease, Gaucher Disease Type
3, GBA Parkinson's Disease and autosomal dominant polycystic kidney
disease (ADKPD). Late-stage/pivotal programs include olipudase, a
first-in-class enzyme replacement therapy (ERT) for the
non-neurological manifestations of acid sphingomyelinase deficiency
(ASMD), and avalglucosidase alfa, a novel ERT for Pompe disease.
Finally, through a strategic collaboration with Alnylam, we are
advancing the development of patisiran for hATTR[4]
amyloidosis and fitusiran for hemophilia A and B, with and without
inhibitors.
Diabetes &
Cardiovascular
Sanofi is committed to sustaining a leadership position in diabetes
and expanding into adjacent co-morbidities. Its late-stage diabetes
pipeline includes sotagliflozin, an investigational SGLT-1/2
inhibitor being developed in collaboration with Lexicon, and
efpeglenatide, a once-weekly GLP-1 being developed in collaboration
with Hanmi. Both of which potentially offer unique patient
advantages. Additionally, Sanofi is leveraging its novel peptide
incretin platform to develop breakthrough assets for diabetes,
obesity and non-alcoholic steatohepatitis (NASH). The lead compound
is an oral dual agonist of GLP-1/GCG which has shown highly
competitive weight loss in the clinic and is expected to enter
phase 3 in obesity in 2018. A phase 2 study in NASH is also due to
start in 2018.
In cardiovascular, Sanofi
continues to work in collaboration with Myokardia on therapeutic
options for genetic forms of cardiomyopathy. The lead compound is
mavacamten, an oral modulator of cardiac myosin, which is in phase
2 for HCM[5] and is
expected to start a registrational phase 2b/3 study in
2018.
Vaccines
Sanofi has six key vaccine projects currently in development, and
priority disease areas include influenza, meningitis and
respiratory syncytial virus (RSV). RSV is the leading cause of
infant viral mortality and represents a new potential category for
Sanofi. The company is taking a complementary dual approach to RSV
with a monoclonal antibody in phase 2, in collaboration with
MedImmune, and a vaccine in phase 1.
Webcast details
The event will be webcast live on Sanofi's website at 8:30 am
CET/2:30 am EST. The webcast details and full presentation will be
made available on Sanofi's Investor Relations webpage and an
Appendix compiling all Sanofi studies registered on
clinicaltrials.gov will also be published.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
|
Media Relations Contact
Kyra Obolensky
Tel. : +33 (0)1 53 77 46 46
mr@sanofi.com |
Investor Relations Contact George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com |
Sanofi Forward-Looking
Statements
This press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates and their underlying assumptions, statements
regarding plans, objectives, intentions and expectations with
respect to future financial results, events, operations, services,
product development and potential, and statements regarding future
performance. Forward-looking statements are generally identified by
the words "expects", "anticipates", "believes", "intends",
"estimates", "plans" and similar expressions. Although Sanofi's
management believes that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could
cause actual results and developments to differ materially from
those expressed in, or implied or projected by, the forward-looking
information and statements. These risks and uncertainties include
among other things, the uncertainties inherent in research and
development of new products, including future clinical trial
results and analysis of clinical data (including post-marketing
data), decisions by regulatory authorities, such as the FDA or the
EMA, regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates. There are additional risks that may
cause actual results to differ materially from those contemplated
by the forward-looking statements, such as the lack of commercial
success of certain product candidates once approved, pricing
pressures, both in the United States and abroad, including
pharmaceutical reimbursement and pricing, the future approval and
commercial success of therapeutic alternatives, risks associated
with intellectual property and any related pending or future
litigation and the ultimate outcome of such litigation, changes in
applicable laws or regulations, the impact of cost containment
initiatives and subsequent changes thereto, as well as those risks
and uncertainties discussed or identified in the public filings
with the SEC and the AMF made by Sanofi, including those listed
under "Risk Factors" and "Cautionary Statement Regarding
Forward-Looking Statements" in Sanofi's annual report on Form 20-F
for the year ended December 31, 2016. Other than as required by
applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements. |
Appendix 1:
R&D Pipeline - New Molecular Entities (*)
R : Registration Study
(other than Phase 3)
O : Opt-in rights
products for which rights have not been exercised yet
-
Immuno-inflammation
-
MS, Neuro, Ophthalmology
-
Oncology
-
Rare Disease
|
|
Phase 3
R
isatuximab Anti-CD38 mAb
+pomalidomide/dexamethasone
Relapsed Refractory Multiple Myeloma |
patisiran (**) siRNA inhibitor targeting TTR
Hereditary ATTR amyloidosis
|
GZ402666 avalglucosidase alfa
Pompe Disease |
fitusiran(9)(**)
siRNA targeting
Anti-Thrombin
Hemophilia |
sotagliflozin (**) Oral SGLT-1&2 inhibitor
Type 1 Diabetes
|
SAR341402 Rapid acting
insulin
Type 1 & Type 2 Diabetes
|
efpeglenatide(**)
Long-acting GLP-1 receptor agonist
Type 2 Diabetes
|
|
Phase 2
SAR156597
IL4/IL13 Bi-specific mAb
Systemic Scleroderma |
SAR425899
GLP-1R/GCG dual agonist
Obesity/Overweight in T2D
|
GZ389988
TRKA antagonist
Osteoarthritis
|
mavacamten(7)(**)
Myosin inhibitor
Obstructive Hypertrophic Cardiomyopathy
|
R
cemiplimab(4)(**)
PD-1 inhibitor mAb
Advanced CSCC (Skin cancer)
|
SAR407899 rho
kinase
Microvascular Angina
|
R
SAR566658
Maytansin-loaded anti-CA6 mAb
Triple Negative Breast Cancer
|
Combination
ferroquine / OZ439(**)
Antimalarial
|
R
olipudase alfa rhASM
Deficiency
Acid Sphingomyelinase Deficiency(6)
|
Tuberculosis
Recombinant subunit vaccine
|
O
SAR339375(6)
miRNA-21
Alport Syndrome |
HIV
Viral vector prime & rgp120 boost vaccine |
venglustat Oral GCS inhibitor
Gaucher related Parkinson's Disease
|
SP0232(8)
mAb(**)
Respiratory syncytial virus
Monoclonal antibody
|
SAR422459 ABCA4 gene
therapy
Stargardt Disease
|
Phase 1
SAR440340(**) Anti-IL33 mAb
Asthma
|
UshStat®
Myosin 7A gene therapy
Usher Syndrome 1B |
SAR439794 TLR4
agonist
Peanut Allergy
|
SAR228810
Anti-protofibrillar AB mAb
Alzheimer's Disease |
SAR408701
Maytansin-loaded anti-CEACAM5 mAb
Solid Tumors |
SAR438335
GLP-1/GIP dual agonist
Type 2 Diabetes |
SAR439459
anti-TGFß mAb
Advanced Solid Tumors |
SAR440181(3)(**) Myosin
activation
Dilated Cardiomyopathy |
O
REGN3767(1)
Anti LAG-3 mAb
Advanced Cancers |
SAR439859
SERD
Metastatic Breast Cancer |
Herpes Simplex Virus Type 2
HSV-2 vaccine |
O
ALN-TTRsc02(2)
Sub-cutaneous siRNA inhibitor targeting TTR
Hereditary ATTR Amyloidosis
|
Respiratory syncytial virus
Infants
Vaccines |
O
ALN-GO1(2)
Investigational RNAi therapeutic
Primary Hyperoxaluria Type 1 (PH1) |
|
-
Regeneron product for
which Sanofi has opt-in right
-
Alnylam product for
which Sanofi has opt-in right
-
Also known as
MYK491
-
Also known as
SAR439684 and REGN2810
-
Also known as Niemann
Pick type B
-
Regulus product for
which Sanofi has opt-in right
-
Also known as
SAR439152 and as MYK461
-
Also known as
MEDI8897
-
Currently on clinical
hold pending outcome of FDA discussion - Expected to resume around
year-end
(*) data related to all studies
published in clinicaltrials.gov
(**) Partnered and/or in
collaboration - Sanofi may have limited or shared rights on some of
these products
Appendix 2: R&D Pipeline -
Additional Indications (*)
R : Registration Study
(other than Phase 3)
O : Opt-in rights
products for which rights have not been exercised yet
-
Immuno-inflammation
-
MS, Neuro, Ophthalmology
-
Oncology
-
Rare Disease
|
|
Registration
VaxiGrip®
QIV IM
Quadrivalent inactivated
influenza vaccine (6-35 months)
|
PR5i DTP-HepB-Polio-Hib Pediatric hexavalent vaccines,
U.S. |
Phase 3
dupilumab(**) Anti-IL4Ralpha
mAb
Asthma 6 - 11 years old
|
R
isatuximab Anti-CD38
mAb
1st line Ti
(IMROZ)
|
dupilumab(**) Anti-IL4Ralpha
mAb
Asthma 12y+ |
R
isatuximab Anti-CD38
mAb
Relapsing Refractory Multiple Myeloma (IKEMA)
|
dupilumab(**) Anti-IL4Ralpha
mAb
Nasal Polyposis
|
Aubagio®
teriflunomide
Relapsing Multiple Sclerosis - Pediatrics
|
Dupixent®(**) Anti-IL4Ralpha
mAb
Atopic Dermatitis 12 - 17 years old |
Sotagliflozin(**) Oral SGLT-1&2 inhibitor
Type 2 Diabetes
|
Dupixent®(**) Anti-IL4Ralpha
mAb
Atopic Dermatitis 6 - 11 years old
|
Praluent®(**)
Anti-PCSK9 mAb
CV events reduction
|
Dupixent®(**) Anti-IL4Ralpha
mAb
Atopic Dermatitis 6 months - 5 years old |
Fluzone® QIV
HD Quadrivalent inactivated
Influenza vaccine - High dose |
R
cemiplimab(1)(**)
PD-1 inhibitor
2nd line
Cervical Cancer
|
Men Quad TT
Advanced meningococcal
ACYW conjugate vaccine
|
R
cemiplimab(1)(**)
PD-1 inhibitor
1st line
NSCLC |
Pediatric pentavalent vaccine
DTP-Polio-Hib
Japan |
|
Phase 2
dupilumab(**)
Anti-IL4Ralpha
mAb
Eosinophilic Esophagitis
|
sotaglifozin(**)
(SAR439954)
SGLT 1 & 2 inhibitor - Worsening Heart Failure
|
sarilumab(**)
Anti-IL6R mAb
Polyarticular Juvenile Idiopathic Arthritis |
mavacamten(4)(**)
Myosin inhibitor
Non-Obstructive Hypertrophic Cardiomyopathy |
sarilumab(**)
Anti-IL6R mAb
Systemic Juvenile Arthritis
|
Rabies VRVg
Purified vero rabies vaccine |
R
cemiplimab(1)(**)
PD-1 inhibitor mAb
Advanced Basal Cell Carcinoma
|
Adacel+ Tdap
booster
|
venglustat Oral
GCS inhibitor
Gaucher Disease Type 3 |
Shan 6 DTP-HepB-Polio-Hib
Pediatric hexavalent vaccine
|
venglustat Oral GCS inhibitor
Fabry Disease
|
|
Phase 1
isatuximab
+ cemiplimab(1)(**)
Anti-CD38 mAb + PD1 inhibitor mAb
Relapsing Refractory Multiple Myeloma |
isatuximab
Anti-CD38 mAb + CyBord(2)
Newly Diagnosed Multiple Myeloma |
SAR439459 + cemiplimab(1)(**)
Anti-TGFß mAb + PD1 inhibitor mAb
Advanced Solid Tumors
|
SAR439859
SERD + Palbociclib
Metastatic Breast Cancer
|
O
cemiplimab(1)(**) +
REGN3767(3)
PD1 inhibitor mAb + anti LAG-3 mAb
Advanced Cancers
|
-
Also known as
SAR439684 and REGN2810
-
Cyclophosmamide +
bortezomib (Velcade) + dexamethasone
-
Regeneron product for
which Sanofi has opt-in right
-
Also known as
SAR439152 and as MYK461
(*) data related to all
studies published in clinicaltrials.gov
(**) Partnered and/or in
collaboration - Sanofi may have limited or shared rights on some of
these products
[1] Partnered
products: cemiplimab, dupilumab, anti-IL33 mAb (Regeneron);
sotagliflozin (Lexicon); efpeglenatide (Hanmi); fitusiran,
patisiran (Alnylam); mavacamten, MYK-491 (Myokardia).
[2] Non-Small
Cell Lung Cancer
[3] The
Principia transaction remains subject to customary regulatory
approvals and has not yet closed.
[4]hATTR =
Hereditary Transthyretin-Mediated Amyloidosis
[5] HCM=
Hypertrophic cardiomyopathy
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Source: Sanofi via Globenewswire
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